Tylenol Sinus Severe
- Product NDC
- 50580-507
- 11-digit product format
- 505800507
- Labeler code
- 50580
- Product ID
- 50580-507_5e691fd8-3462-c044-e063-6294a90ad886
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-15
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tylenol Sinus Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-507-01 | Tylenol Sinus Severe | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 16 | |
| 50580-507-01 | Tylenol Sinus Severe | 2 in 1 CARTON | TABLET, COATED | 2 | 16 | |
| 50580-507-02 | Tylenol Sinus Severe | 2 in 1 CARTON | TABLET, COATED | 2 | 16 | |
| 50580-507-02 | Tylenol Sinus Severe | 3 in 1 PACKAGE | TABLET, COATED | 3 | 16 | |
| 50580-507-03 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 16 | |
| 50580-507-04 | Tylenol Sinus Severe | 50 in 1 CARTON | TABLET, COATED | 50 | 16 | |
| 50580-507-04 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-507-01 | EA - Each | 50580-507 | ee10d929-4cd2-4906-8663-c84fe7e61be4 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-507 | TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC] | 16 | Current NDC, Legacy NDC, 7 package rows | 20241103_7a60184f-91a9-4b85-b243-871deca63450.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5172dc01-4e7f-3307-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51c44970-06e5-082e-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 54236151-37db-0b5a-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 52542774-fd05-640c-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dca689-e4a0-5526-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f2d18f6-935f-9215-e053-2a91aa0aedd3 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTRMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6fb28fa1-ebbb-64bf-e053-2991aa0a1de4 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5213ca7f-5a78-6471-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 6f7ba256-ed14-5fe0-e053-2a91aa0aacc1 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 6f7bf92d-4aaf-86e0-e053-2991aa0a2d91 | 2025-12-04 | Warnings | M012 |
| Afrin NoDrip Allergy Sinus Night | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | b023a571-7e54-7c63-e053-2a95a90a0f78 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE | Bayer HealthCare LLC. | b1cd7d9f-0ab4-21ce-e053-2a95a90a8c3d | 2025-12-04 | Warnings | M012 |
| Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3231869-8ddf-9d17-e053-2995a90ae6d5 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Multi Symptom Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | ae7cf41e-b618-d6bb-e053-2a95a90a6692 | 2025-12-04 | Warnings | M012 |
| Afrin Allergy Sinus Nasal | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | c2d903bf-5c51-82d7-e053-2995a90aea49 | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold, Cough and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 351d3c5c-05c8-921a-e063-6394a90abef9 | 2025-12-04 | Warnings | M012 |
| Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | e3b239bd-ffc7-600c-e053-2a95a90a3b3b | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | M012 |
| Coricidin HBP Maximum Strength Cold and Flu Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e4f3f906-2252-21d1-e053-2a95a90a85df | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-507-01 | 50580050701 | 2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2015-05-15 | 0000-00-00 | No | No | Current |
| 50580-507-02 | 50580050702 | 3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK | 3 carton | 2020-07-06 | No | No | Current | |
| 50580-507-03 | 50580050703 | 2 TABLET, COATED in 1 POUCH (50580-507-03) | 2017-07-17 | 0000-00-00 | No | No | Current | |
| 50580-507-04 | 50580050704 | 50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH | 50 pouch | 2017-07-17 | 0000-00-00 | No | No | Current |
| 50580-507-72 | 50580050772 | 3 CARTON in 1 CARTON (50580-507-72) / 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK | 3 carton | 2026-03-16 | No | No | Current |